Emily Hayhurst

How to get the most out of medical device user testing

Medical Device User Testing Do you know the most overlooked step in creating a useful medical device?

It might sound surprising, but if we were to look at a graveyard of failed products, more often than not they fail because, while they deliver their promise, they fail the user. Do not underestimate how critical it is to seek user feedback in the design process. User feedback is essential for making educated design decisions.

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Nadia Routhier

Cardboard Mock-Ups Vs. 3D Printing for Rapid Iterations

Rapid Prototyping Human FactorsWhen I joined StarFish Medical I was pretty stoked about the 3D printer and marvelled at the prints created by the Mechanical Engineers and Industrial Designers. As a Human Factors Engineer in product development my favorite challenges are the ones that call on imaginative solutions for investigating and testing use-related ideas and concepts for new products.

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XR is about to Revolutionize Medical Device Design

XR Medical Device Design

Extended Reality (XR) is going to fundamentally shift how medical devices are researched, designed, and promoted. In this post, we’ll discuss how XR changes the future of medical device development and the benefits of employing XR. But first, let’s clarify what XR is and why now is the time to pay attention to it.
Long ago, Virtual Reality was hyped as the next disruptor technology. Up until this point, it has failed the hype. However, with recent advancements in software and cheaper headsets, this is about to change. There now exists a spectrum of real-to-virtual combined environments that are more accessible.

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FAQs for Potential EE Co-ops

Electrical Engineering Co-op ExperiencesCo-op students answer FAQs and share their experiences

Want to experience the Biomedical Device industry from a front row seat? Consider doing a co-op term with an Electrical Engineering (“EE”) team. Diana Cancelliere and Holden Jones answer FAQs that potential EE co-ops may have.
“The hands-on industry experience gained during our co-op term at StarFish Medical this summer gave us the opportunity to apply Electrical Engineering concepts to real-life Biomedical Engineering challenges. We want to share this experience with other students with answers to questions they should ask when considering an EE co-op.”

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Kevin Meric

Why Laser Cutting is My New Go-To Iterative Design Tool

Laser Cutting Device Design The design process is all about making design decisions. Whether the outcome is good or bad, the faster you can validate these decisions, the better your design becomes because you are iterating and learning. My new favorite tool to iterate is our laser cutting machine.
I must admit that before joining StarFish, laser cutting was not one of my “go-to” tools as I found it difficult to dial in precise tolerances.

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Deborah Pinchev

UK Medical Device Brexit Implications

Medical Device Brexit ImplicationsOn June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be of interest to medical device manufacturers.

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Raje Devanathan

Digital Health Technology (DHT) for Clinical Investigations – FDA Draft Guidance Analysis

 FDA DHT Clinical Investigations Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems.
The FDA thinks we can use these kinds of data for better and safer medical devices. They have built a set of rules around what and how that data can be generated and used.This blog examines their draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. You should also read our previous blog on the future of DHT.

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Maria Gonzalez

Quality Management System Regulation (QMSR) Alignment with ISO 13485:2016

QMSR ISO 13485:2016 AlignmentMany organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past.
The FDA aims to accomplish this via a proposed rule in which manufacturers are allowed to create a robust Quality Management System (QMS) that complies with a single set of requirements. It also increases international collaboration between the FDA and major markets (Europe, Canada, Australia, Japan, etc.) by minimizing the country specific requirements needed to comply with the Federal Food, Drug and Cosmetic Act (FD&C Act).

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Helen Simons

5 Tips for medical device cyber security

Medical Device Cyber SecurityEditor’s note: This is the 2022 update to the August 2015 “5 Tips for medical device cyber security” blog by Vincent Crabtree. Read the original one here.
In this modern world, cyber security and data protection has become a familiar topic to us all. From agreeing to cookies on website, to data privacy agreements to sign, to ever increasing log ins and access controls, we all feel the impact of cybersecurity protections.
They may seem burdensome to the user but they are there for a reason. As devices and websites collect more and more data about us and our habits, this data becomes valuable to those wishing to exploit it. Cyber security attacks and data privacy breaches are a relatively common occurrence these days.

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Doug Bailey

How to Create a Useful Medical Device Project Plan

Medical Device Project PlanI could spend a lot of time trying to make sure my medical device project plan is useful. But most effective proof for me is hearing this phrase: “Hey Doug, I was looking at the plan…”.
Let’s count the wins in that phrase: 1) Someone thought about accessing the plan. AKA, they saw value in the plan. 2) Someone could access the plan. 3) Someone could navigate the plan to get the information they were seeking.

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T. David Pyron

Risk Management for Medical Device Projects

Device Development Risk ManagementMy goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project.
In my experience, dealing with the fires of the day always take precedent over managing things that might not happen in the future. (spoiler alert: those fires might have been prevented by project-managing the things that haven’t happened yet).

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